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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K980863
Device Name DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
Applicant
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact SHARMINI ATHERAY
Correspondent
Dumex Medical Surgical Products, Ltd.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact SHARMINI ATHERAY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/05/1998
Decision Date 05/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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